Medical sterilization and storage cabinet with multidirectional access

ABSTRACT

Methods, devices and program products are provided for a medical instrumentation storage cabinet. First and second instrumentation retention trays are configured to receive surgical instruments. The housing includes a top plate, a bottom shelf and at least one intermediate shelf there between. The bottom and intermediate shelfs and the first and second instrumentation retention trays include a plurality of holes there through to allow passage of a sterilization medium during a sterilization process. Standoffs are distributed about a perimeter of the housing. The standoffs separate the intermediate shelf from the top plate and bottom shelf to define first and second tray storage areas there between. The first and second tray storage areas have a shape and dimension to receive the first and second instrumentation retention trays. The standoffs are spaced apart from one another to define tray passages there between. The tray passages re sized and located to allow both of the first and second instrumentation retention trays to be inserted into the housing and opened to an open position relative to the housing in at least three directions.

RELATED APPLICATION

The present application relates to, and claims priority from ProvisionalApplication Ser. No. 62/613,290, titled “MEDICAL STERILIZATION ANDSTORAGE CABINET WITH MULTIDIRECTIONAL ACCESS” and filed Jan. 3, 2018,the full and complete subject matter of which is expressly incorporatedherein by reference in its entirety.

BACKGROUND

Embodiments of the present disclosure generally relate to medicalinstrumentation containers and more specifically to medicalsterilization storage cabinets.

In the 1980s, sterilization container systems and surgical trays weregenerally introduced in the U.S. The container systems and surgicaltrays varied in design, mechanics and construction materials. Today,these container systems utilize various packaging options to organizeand utilize surgical instruments. Rigid reusable sterile containersystems are used for the packaging, transportation, and storage ofinstruments prior to, during, and after sterilization. The containersystems include a broad line of products including lids and bottoms invarious sizes, with assorted accessories such as baskets, filters,clamps, organization tools, containment devices, and tamper evidentlocks. Reusable rigid sterile containers offer some advantages overother packing options, such as wrap and peel pouches. For example, therigid sterile containers may provide economic and environmentalbenefits, along with increased safety.

However, conventional container and tray systems experience certainlimitations. In an operating room, nurses and/or surgical team membersseek to deliver instruments and implants to the surgeon in a timely andefficient manner. However, surgical procedures can extend over severalhours and involve the user of a large number of different surgicalinstruments. Surgical procedures are unpredictable and the nurses and/orsurgical team are not able to anticipate which instrumentation thesurgeon will need next. Also, multiple nurses/team members participatein providing instruments to the surgeon. As one example, new nurses andteam members may enter a surgical room at intermediate points during theprocedure and supplement or take over for other nurses who start theprocedure. Procedure length, complexity, and staff changes render itdifficult to keep track of the instruments and assist a surgeon in themost efficient manner.

An operating room environment has limited table space and therefore itis not practical to neatly set out all of the surgical instruments thatmay be needed during the procedure. Instead, the conventional containersystems generally resemble a large suitcase or briefcase with an opentop and with numerous trays stacked upon one another. At the beginningof the procedure, the trays are removed from the container and thecontainer is placed to the side. The trays are spread out on tables.Given that one procedure may involve numerous surgical instruments,multiple trays of instruments are spread across the limited table space.The trays are also stacked upon one another in a generally un-organizedmanner. When an instrumentation from a lower tray in a stack is needed,the trays upon the tray of interest are moved and re-stacked upon othertrays. This pattern of moving and re-stacking instruments trays resultsin a cluttered and disorganized assembly of trays and loosely organizedinstruments spread about the surgical environment. Consequently, itbecomes difficult for nurses/team members to locate individualinstruments in a timely and efficient manner when requested by thesurgeon, which can slow down the procedure and efficiency in theenvironment.

Moreover, during an operating room procedure, conventionalinstrumentation trays are taken out of any sterile container andspread/distributed across any available table space within the operatingroom. Additionally or alternatively, a large number of the instrumentswithin the trays may be removed from the trays during the preparation ofthe operating room with the estimates being laid out upon tables withinthe operating room. It is desirable to lay out as many of theinstruments as practical and/or spread out as many instrumentation traysas possible in order that the clinicians may see the availableinstruments and have ready access thereto without stacking andunstacking numerous instrumentation trays in the middle of a procedure.

However, while an operating room is generally a sterile environment,numerous contaminants are introduced throughout the room during amedical procedure. Instruments that are exposed to the operating roomenvironment are similarly exposed to such contaminants. The longer thatinstruments are exposed to the operating room environment, the greaterthe level contaminants collected by the instrumentation and/or thegreater the risk that the instrumentation will collect and unduly highlevel of contaminants. Medical instrumentation contamination remains asubstantial concern within the medical profession.

SUMMARY

In accordance with embodiments herein, a medical instrumentation storagecabinet is provided that comprises: first and second instrumentationretention trays configured to receive surgical instruments; a housingincluding a top plate, a bottom shelf and at least one intermediateshelf there between, one or more of the top plate, the bottom shelf, theintermediate shelf or the first and second instrumentation retentiontrays including a plurality of holes there through to allow passage of asterilization medium during a sterilization process; and the housingseparating the intermediate shelf from the top plate and bottom shelf todefine first and second tray storage areas there between, the first andsecond tray storage areas configured to receive the first and secondinstrumentation retention trays, respectively; and tray passagesprovided in the housing, the tray passages located to allow both of thefirst and second instrumentation retention trays to be inserted into thehousing and opened to an open position relative to the housing in atleast three directions.

In accordance with embodiments herein, a method of providing a medicalinstrumentation storage cabinet is provided that comprises: configuringfirst and second instrumentation retention trays to receive surgicalinstruments; providing a housing including a top plate, a bottom shelfand at least one intermediate shelf there between, one or more of thetop plate, the bottom shelf, the intermediate shelf or the first andsecond instrumentation retention trays including a plurality of holesthere through to allow passage of a sterilization medium during asterilization process; and separating the intermediate shelf from thetop plate and bottom shelf to define first and second tray storage areasthere between, the first and second tray storage areas configured toreceive the first and second instrumentation retention trays,respectively; and locating tray passages about a perimeter of thehousing to allow both of the first and second instrumentation retentiontrays to be inserted into the housing and opened to an open positionrelative to the housing in at least three directions.

In accordance with an embodiment, a medical sterilization and storagecabinet is provided with a new and convenient manner to accessinstruments within the storage cabinet while in a variety of healthcaresettings from the operating room theatre, emergency room settings,hospital rooms, ambulatory surgery centers, doctors' offices, dentalclinics and the like. In accordance with embodiments herein, asterilization cabinet is provided that affords a unique and flexiblestorage solution system to organize and house surgical trays andinstruments in trays that the medical staff can readily access withoutstacking and unstacking trays, while also providing the capability forthe trays to open in multiple directions. The trays are reusable, rigid,sterile containers that can withstand numerous autoclave processes. Inaccordance with embodiments herein, a sterilization and storage cabinetis provided that affords a new solution for manufacturers of healthcareequipment who are looking for the next generation of surgical tray andinstrumentation management.

Among other things, the sterilization and storage cabinets describedherein reduce the potential for contamination as compared toconventional instrumentation storage systems. The sterilization andstorage cabinets retain trays in a closed position, in which the opentop of the tray is enclosed within the cabinet and generally isolatedfrom the environment within the operating room or other clinical area.The trays may be retained enclosed in a sheltered environment within thecabinet for a substantial portion of the medical procedure, only openingthe trays at or near the time when the instruments therein are to beused. By reducing the amount of time in which the instruments areexposed to the environment of the operating room or other clinical area,embodiments herein substantially reduce the exposure time tocontaminants within the environment and substantially reduce the levelof contamination experienced by such instruments prior to usage.

The sterilization and storage cabinet offers cost effective, convenientsolutions to a variety of healthcare markets. Additionally, thesterilization and storage cabinet can be sterilized with blue-wrap orused with rigid containers, with market segment by application dividedbetween hospitals with emergency/operating rooms and other medicalinstitutions such as urgent care clinics and dental care offices. Thesterilization and storage cabinet herein provides a packaging optionwhich provides a cost effective, efficient organization and utilizationof surgical instruments and trays. A sterilization and storage cabinetis provided that affords a durable, long-lasting, reusable packagingsystem for sterilization, storage, and transport of medical devices. Asterilization and storage cabinet is provided that affords a new,innovative, convenient, multi-directional, removable, more flexible andefficient access to storage trays and instruments in a limited spaceenvironment with the flexibility to be “blue wrapped” or used withavailable rigid containers. The multidirectional drawer system allowsease of use in tight areas, offers an ability to organize surgicalinstrumentation space, and maintains sterility. Embodiments hereinprovide a design that protects surgical instruments with a hard andsheltered structure. Embodiments herein provide an ergonomic design andhandling system that enables proper, easy and safe transportation.

In accordance with embodiments herein, a medical instrumentation storagecabinet is provided that comprises first and second instrumentationretention trays configured to receive surgical instruments; a housingincluding a top plate, a bottom shelf and at least one intermediateshelf there between, one or more of the top plate, the bottom shelf, theintermediate shelf or the first and second instrumentation retentiontrays including a plurality of holes there through to allow passage of asterilization medium during a sterilization process; and standoffsdistributed about a perimeter of the housing, the standoffs separatingthe intermediate shelf from the top plate and bottom shelf to definefirst and second tray storage areas there between, the first and secondtray storage areas configured to receive the first and secondinstrumentation retention trays, respectively. The standoffs are spacedapart from one another to define tray passages there between, the traypassages sized and located to allow both of the first and secondinstrumentation retention trays to be inserted into the housing andopened to an open position relative to the housing in at least threedirections.

Optionally, the first and second instrumentation retention trays have abaseplate and walls at least partially surrounding the baseplate, thebaseplate configured to receive surgical instruments, the walls having aheight that corresponds to a height of the first and second storageareas. Optionally, the at least three directions include at least oneside and opposite ends of the housing. Optionally, the at least threedirections include at least one end and opposite sides of the housing.Optionally, the standoffs are spaced apart to define tray passages infour directions including both sides and both ends of the housing.Optionally, the top plate, bottom and intermediate shelfs and first andsecond instrumentation retention trays are formed of a sterilizationtolerant material. Optionally, one or more of the top plate, and bottomand intermediate shelfs include tabs distributed about the perimeter,the tabs extending in a transverse direction to at least partially formthe standoffs that separate the intermediate shelf from the top andbottom shelfs. Optionally, the cabinet may further comprise a bracketconnector joined to corners of the top plate, bottom shelf andintermediate shelfs to at least partially form the standoffs.

At least one of the first and second instrumentation retention trays mayinclude feet provided on a bottom surface thereof, the feet separatingthe bottom surface from a top surface of the corresponding adjacentbottom and/or intermediate shelf to allow lateral distribution of thesterilization medium during the sterilization process. The top plate andbottom shelf may include rails formed along side and end edges thereof,the rails on the top plate facing and aligning with the rails on thebottom shelf, the housing further comprising side and end doors slidablyreceived within the corresponding rails, the side and end doors slidingbetween open and closed positions to expose and cover the side and endtray passages. The rails along one or more of the sides and ends of thehousing include a door retention segment configured to retain acorresponding side and end door when in an at least partially openposition, the side and end doors having front bottom edges configured toengage a surface on which the cabinet is positioned while the doorretention segments retain a rear segment of the side and end doors toform a counterbalance lever to resist tipping by the housing when one ormore of the first and second instrumentation retention trays ispartially removed from the corresponding first or second tray retentionarea.

Optionally, the first and second tray storage areas have heights thatsubstantially match heights of the first and second instrumentationretention trays, respectively, such that the housing supports the firstand second instrumentation retention trays when opened to a fully openposition. Optionally, the cabinet may further comprise third, fourth andfifth instrumentation retention trays, wherein the first through fifthinstrumentation retention trays are independently insertable andopenable relative to the housing in the at least three directions.

In accordance with embodiments herein, a method is provided of providingmedical instrumentation storage cabinet. The method comprisesconfiguring first and second instrumentation retention trays to receivesurgical instruments; providing a housing including a top plate, abottom shelf and at least one intermediate shelf there between, one ormore of the top plate, the bottom shelf, the intermediate shelf or thefirst and second instrumentation retention trays including a pluralityof holes there through to allow passage of a sterilization medium duringa sterilization process; distributing standoffs about a perimeter of thehousing, the standoffs separating the intermediate shelf from the topplate and bottom shelf to define first and second tray storage areasthere between, the first and second tray storage areas configured toreceive the first and second instrumentation retention trays,respectively; spacing the standoffs apart from one another to definetray passages there between; and sizing and locating the tray passagesto allow both of the first and second instrumentation retention trays tobe inserted into the housing and opened to an open position relative tothe housing in at least three directions.

Optionally, the first and second instrumentation retention trays have abaseplate and walls at least partially surrounding the baseplate, themethod further comprising inserting surgical instruments on thebaseplate, the walls having a height that corresponds to a height of thefirst and second storage areas. Optionally, the method may compriseinserting and/or opening the first instrumentation retention traythrough one side, inserting and/or opening the first instrumentationretention tray through a first end of the housing and inserting and/oropening the first instrumentation retention tray through an oppositesecond end of the housing. Optionally, the method may comprise insertingand/or opening the first instrumentation retention tray through a firstside of the housing, inserting and/or opening the first instrumentationretention tray through a second side of the housing and inserting and/oropening the first instrumentation retention tray through an end of thehousing.

Optionally, the method may comprise inserting and/or opening the firstinstrumentation retention tray through a first side of the housing,inserting and/or opening the first instrumentation retention traythrough a second side of the housing and inserting and/or opening thefirst instrumentation retention tray through an end of the housing; andinserting and/or opening the second instrumentation retention traythrough the first side of the housing, inserting and/or opening thesecond instrumentation retention tray through the second side of thehousing and inserting and/or opening the second instrumentationretention tray through the end of the housing. Optionally, the methodmay comprise forming the top plate, bottom and intermediate shelfs andfirst and second instrumentation retention trays of a sterilizationtolerant material. Optionally, the method may comprise loading the firstand second instrumentation retention trays with instrumentation,inserting the first and second instrumentation retention trays intocorresponding first and second tray storage areas and loading thecabinet into a chamber and introducing a sterilization medium to thechamber, the sterilization medium propagates through interior passageswithin the cabinet to sterilize surfaces of the cabinet. Optionally, themethod may comprise maintaining a space between the first and secondinstrumentation retention trays and bottom and intermediate shelfs todefine air passages that allow a sterilization medium to touch upper andlower surface of the first and second instrumentation retention traysand bottom and intermediate shelfs. The sterilization medium is at leastone of heated air, steam, liquid or vapor chemicals. Optionally, themethod may comprise organizing instrumentation within the first andsecond instrumentation retention trays based on a predeterminedprocedure such that a first set of instrumentation in the firstinstrumentation retention tray corresponds to a first aspect of thepredetermined procedure and a second set of instrumentation in thesecond instrumentation retention tray corresponds to a second aspect ofthe predetermined procedure. Optionally, the method may comprise markingthe first and second instrumentation retention trays with indiciaindicative of a content thereof, wherein the indicia indicate at leastone of color coding, descriptive text, or numbers. Optionally, themethod may comprise partially opening a door on one or more side or endof the cabinet and retaining a portion of the door in rails in thecabinet, the door forming a counterbalance lever to resist tipping bythe housing when one or more of the first and second instrumentationretention trays is partially removed from the corresponding first orsecond tray retention area.

In accordance with embodiments herein, a method is provided thatcomprises: providing a collection of multi-level cabinets that includestage-1 and stage-2 multi-level cabinets for use in connection with atleast first and second stages, respectively, of a surgical procedure,each of the stage-1 and stage-2 cabinets comprising: a housing includinga top plate, a bottom shelf and at least one intermediate shelf therebetween, the housing separating the intermediate shelf from the topplate and bottom shelf to define first and second tray storage areasthere between, the first and second tray storage areas configured toreceive the first and second instrumentation retention trays,respectively; and tray passages located on at least a side and an end ofthe housing and communicating with the first and second tray storageareas to allow both of the first and second instrumentation retentiontrays to be inserted into the housing and opened to an open positionrelative to the housing in at least two directions; providing thestage-1 cabinet with instrumentation retention trays loaded withinstrumentation for use with actions or tasks performed during the firststage of the surgical procedure; and providing the stage-2 cabinet withinstrument retention trays loaded with instrumentation for use withactions or tasks performed during the second stage of the surgicalprocedure.

In accordance with embodiments herein, the providing the stage-1 andstage-2 cabinets comprises loading the instruments in theinstrumentation retention trays and loading the instrumentationretention trays into the stage-1 and stage-2 cabinets. Optionally, theproviding the stage-1 and stage-2 cabinets comprises stacking thestage-1 and stage-2 cabinets in an operating room environment.Optionally, the method further comprising: utilizing the collection ofmulti-level cabinets during the surgical procedure; opening theinstrument retention trays of the stage-1 cabinet during the first stagewhile maintaining the instrument retention trays of the stage-2 cabinetclosed in an enclosed and sheltered environment during the first stage.Optionally, the method further comprising maintaining the instrumentretention trays of the stage-1 and stage-2 cabinets closed in anenclosed and sheltered environment until one or more of the instrumentsin a corresponding one of the instrument retention trays is needed foruse in the surgical procedure to reduce a potential for contamination.Optionally, the surgical procedure includes an exposure stage, a screwinsertion stage and a rod manipulation stage, the multi-level cabinetsincluding at least one instrument retention tray that includes rodmanipulation instruments for use during the rod manipulation stage, themethod further comprising maintaining the at least one instrumentretention tray, that includes the rod manipulation instruments, in anenclosed and sheltered environment within the corresponding multi-levelcabinet until the surgical procedure advances to the rod manipulationstage. Optionally, the at least two directions include at least one endand at least one side of the housing. Optionally, the tray passages inthe stage-1 cabinet are positioned to allow the instrumentationretention trays therein to be inserted into the housing and opened to anopen position relative to the housing through at least one end and atleast one side, wherein the tray passages in the stage-2 cabinet arepositioned to allow the instrumentation retention trays therein to beinserted into the housing and opened to an open position relative to thehousing through at least one end and at least one side. Optionally, thetray passages in the stage-1 and stage-2 cabinets are positioned toallow the instrumentation retention trays therein to be inserted intothe corresponding housings and opened to an open position relative tothe corresponding housings through at least three directions.

In accordance with embodiments herein, a medical instrumentation storagecabinet system is provided comprising: a collection of multi-levelcabinets that include stage-1 and stage-2 multi-level cabinets for usein connection with at least first and second stages, respectively, of asurgical procedure, each of the stage-1 and stage-2 cabinets comprising:a housing including a top plate, a bottom shelf and at least oneintermediate shelf there between, the housing separating theintermediate shelf from the top plate and bottom shelf to define firstand second tray storage areas there between, the first and second traystorage areas configured to receive the first and second instrumentationretention trays, respectively; and tray passages located on at least aside and an end of the housing and communicating with the first andsecond tray storage areas to allow instrumentation retention trays to beinserted into the housing and opened to an open position relative to thehousing in at least two directions.

Optionally, the instrumentation retention trays, in the stage-1 cabinet,are loaded with instrumentation for use with actions or tasks performedduring the first stage of the surgical procedure; and theinstrumentation retention trays, in the stage-2 cabinet, are loaded withinstrumentation for use with actions or tasks performed during thesecond stage of the surgical procedure. Optionally, the tray passages inat least on of the stage-1 or stage-2 cabinets are located to allow theinstrumentation retention trays to be inserted into the housing andopened to an open position relative to the housing in at least threedirections. Optionally, the stage-1 and stage-2 cabinets are stacked onone another. Optionally, one or more of the top plate, the bottom shelf,the intermediate shelf or the instrumentation retention trays include aplurality of holes there through to allow passage of a sterilizationmedium during a sterilization process. Optionally, the tray passages areconfigured to allow the instrument retention trays of the stage-1cabinet to be open during the first stage while maintaining theinstrument retention trays of the stage-2 cabinet closed in an enclosedand sheltered environment during the first stage.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a partially open perspective view of a medicalinstrumentation storage cabinet formed in accordance with embodimentsherein.

FIG. 1B illustrates the various components of the housing and a set ofinstrumentation retention trays.

FIG. 2 illustrates a top front perspective view of the cabinet with theside door and the side door slid within corresponding rails to apartially open position.

FIG. 3 illustrates a top front perspective view of the cabinet with theside door partially open and the end door slid fully open.

FIG. 4A illustrates the various components of the cabinet in an explodedarrangement.

FIG. 4B illustrates instrumentation retention trays with instrumentationalignment features mounted therein in accordance with embodimentsherein.

FIG. 5A illustrates an enlarged perspective in view of a corner of thehousing formed in accordance with embodiments herein.

FIG. 5B illustrates an enlarged perspective view of the corner of thebottom shelf.

FIG. 5C illustrates a front perspective view of a corner connectorformed in accordance with an alternative embodiment.

FIG. 5D illustrates a rear perspective view of a corner connector formedin accordance with an alternative embodiment.

FIG. 6 illustrates a portion of the cabinet while loaded into a chamberconfigured to perform a sterilization process.

FIG. 7 illustrates a side perspective view of an intermediate shelf anda tray configured to cooperate with one another.

FIG. 8 illustrates a top front perspective view of a cabinet with ahousing that includes more than two intermediate shelves.

FIG. 9A illustrates a top plan view of a tray formed in accordance withan embodiment herein.

FIG. 9B illustrates an end view of a top plate hinge assembly that maybe mounted on a top of a cabinet housing in accordance with embodimentsherein.

FIG. 9C illustrates a top plan view of the top plate hinge assembly ofFIG. 9B, when mounted to a housing of a cabinet in accordance withembodiments herein.

FIG. 10 illustrates a corner perspective view of a pair of cabinetsnested with one another in accordance with an embodiment herein.

FIG. 10A illustrates a cabinet linking member secured to post providedon respective brackets in accordance with embodiments herein.

FIG. 11 illustrates a process for organizing a cabinet system to beutilized in a multi-stage surgical procedure in accordance withembodiments herein.

FIG. 12 illustrates a front perspective view of a cabinet system joinedto one another in an O.R. in accordance with an embodiment herein.

DETAILED DESCRIPTION

It will be readily understood that the components of the embodiments asgenerally described and illustrated in the figures herein, may bearranged and designed in a wide variety of different configurations inaddition to the described example embodiments. Thus, the following moredetailed description of the example embodiments, as represented in thefigures, is not intended to limit the scope of the embodiments, asclaimed, but is merely representative of example embodiments.

Reference throughout this specification to “one embodiment” or “anembodiment” (or the like) means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” or the like in various placesthroughout this specification are not necessarily all referring to thesame embodiment.

Furthermore, the described features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments. In thefollowing description, numerous specific details are provided to give athorough understanding of embodiments. One skilled in the relevant artwill recognize, however, that the various embodiments can be practicedwithout one or more of the specific details, or with other methods,components, materials, etc. In other instances, well-known structures,materials, or operations are not shown or described in detail to avoidobfuscation. The following description is intended only by way ofexample, and simply illustrates certain example embodiments.

Throughout the present description, the terms “front”, “back”, “side”,“end”, “forward”, “rear”, and “rearward” are used as relative terms withrespect to a reference perspective. The reference perspective may bedefined by one or more of i) an orientation of a cabinet whilepositioned on a table or other support surface, such as during acleaning process or medical procedure, ii) a surface of the cabinetfacing and in closest proximity to medical personnel during cleaning,loading, or a medical procedure, iii) an orientation in which medicalinstruments are stored in the cabinet, and/or iv) a shape of thecabinet. For example, when the cabinet is shaped in an elongatedconfiguration, such as with a rectangular, elliptical or oval shape, thecabinet would generally include a longitudinal axis extending along alength of the cabinet and a transverse axis. By way of example, the“sides” of the cabinet may represent the surfaces that extends generallyparallel to the longitudinal axis, while the “ends” of the cabinet mayrepresent the surfaces of the cabinet that extend generally parallel tothe transverse axis. The term “side” may be used to collectively referto either or both of the front and back surfaces of the cabinet. Thesides and ends of the cabinet may be defined simply based upon themanner in which the cabinet is oriented when the cabinet is positionedon a table or other supporting surface during cleaning, loading, or amedical procedure. The cabinet may be positioned in various orientationsdepending upon the available table space. When a cabinet is placed on atable, the surface of the cabinet facing the medical personnel and inclosest proximity to the medical personnel would represent the front. Asanother example, the reference perspective may be defined based on theorientation of the medical instruments when stored. For example, theinstruments may be loaded into a tray with bottom ends of theinstruments facing one wall of the tray. When the trays are loaded intothe cabinet, the surface of the cabinet, toward which the bottom ends ofthe instruments face may represent a “front” or “back” depending uponthe direction in which the medical personnel prefer the instruments tobe oriented.

The terms “autoclave” and “autoclaving” refer to sterilization systemsand processes to process medical instruments in a pressurized vesselswhich require exposure to elevated pressure and temperature.

The term “instrumentation” includes, but is not limited to, instruments,implants, trial implants and the like.

The term “sterilization process” refers to any process utilized to cleanand sterilize medical instruments by an amount accepted by anappropriate medical body or as defined by a corresponding standardsbody. As a non-limiting example, an autoclave system may be used in asterilization process. As another example, steam may be used forsterilizing instruments, trays, and cassettes. According to the Centerfor Disease Control and Prevention, steam under pressure is at least oneprocess of choice whenever possible as it is considered safe, fast, andthe cost-effective for health care facilities.

The term “sterilization tolerant material” refers to materials that maybe utilized to form components of the cabinet described herein wheresuch materials are able to withstand repeated exposure to thetemperatures, pressures, chemicals and other environmentalcharacteristics to which the cabinet is exposed during a sterilizationprocess. Non-limiting examples of sterilization tolerant materialsinclude aluminum and stainless steel. Other non-limiting examples ofsterilization tolerant materials include certain high-performancepolymers, such as the Radel® polyphenylsulfone (PPSU) materials bySolvay Specialty Polymers of Alpharetta, Ga.

The term “surgical procedure setting” refers to any room or areautilized for a surgical procedure, including but not limited to anoperating room, emergency room, hospital patient room, ambulatorysurgery centers, doctors' offices, dental clinics and the like. Theterms “open position” and “open state” refer to a position of a trayrelative to the cabinet, in which a leading section of the tray isexposed from the cabinet while a trailing section of the tray remainsheld within the cabinet.

The term “fully open” refers to a position in which a tray is opened toexpose at least 90% of an instrumentation storage area within the tray,while no more than 10% of the instrumentation storage area within thetray remains covered within the cabinet.

The term “removed position” refers to a tray position in which the trayis entirely separated and removed from the cabinet.

FIG. 1A illustrates a partially open perspective view of a medicalinstrumentation sterilization and storage cabinet 100 formed inaccordance with embodiments herein. The medical instrumentation storagecabinet 100 includes a housing 102 that includes a series of stackedcomponent layers (generally referred to as plates and shelves) that arerigidly affixed to one another and that are configured to slidablyreceive multiple instrumentation retention trays. As explained herein,the housing 102 is constructed to enable the instrumentation retentiontrays to be inserted and removed (partially or wholly) in multipledirections. For example, trays may be pulled out until 50%, 75%, 90% ofthe tray is exposed. Separate trays may be pulled out partially from theone or both sides and one or both ends to expose the content of three orfour trays simultaneously while the trays are supported by the cabinet100.

The housing 102 includes sides 105, 107 that extend parallel to alongitudinal axis 124 and ends 109, 111 that extend parallel to atransverse axis 144. The longitudinal and transverse axes 124, 144 areprovided as non-limiting references and should not be interpreted tolimit the shape or dimensions of the cabinet 100 in any manner. In theexample of FIG. 1A, the cabinet 100 is formed in a generally rectangularshape, a length of which extends along the longitudinal axis 124 and awidth of which extends along the transverse axis 144. It is recognizedthat the cabinet 100 may be formed in numerous alternative shapes. Asnon-limiting examples, the cabinet may be configured with a rectangularshape, a triangular shape, a circular shape, an elliptical or ovalshape, a trapezoidal shape, and the like.

During a medical procedure, once the doors 120, 121 are removed, theindividual trays 114-116 may remain enclosed within the cabinet 100until a desired instrumentation is needed therefrom. Once aninstrumentation is removed from an individual tray 114, 116, the traymay be returned to the closed position and/or may remain open dependingupon whether additional instruments in the tray are expected to beneeded in the near future within the procedure. The cabinet 100 allowsan easy mechanism for accessing trays and thus affords an equally easymechanism for the user to close a tray after an individualinstrumentation is removed. Consequently, in an effort to limitcontamination, operating room personnel would be able to close a trayonce an individual instrumentation is removed, and not necessarily leaveall of the trays open and distributed across tables within the operatingroom. The operating room personnel could open and close the traysrepeatedly throughout the procedure, without slowing down the procedureor experiencing difficulty in locating particular instruments, and thuswould substantially reduce the amount of time that clean unusedinstruments are exposed to the operating room general environment.Consequently, by providing a cabinet that readily allows access totrays, even while stacked, embodiments herein facilitate a manner ofcontamination conscious management that retains clean unused instrumentsin an enclosed environment (generally isolated from contamination in theoperating room) until such instruments are needed.

FIG. 1B illustrates the various components of the housing 102 and a set103 of instrumentation retention trays 114-116. The housing 102 includestop plate 104, bottom shelf 106 and at least one intermediate shelf 108there between. In the example of FIGS. 1A and 1B, first and secondintermediate shelves 108, 110 are provided. The housing 102 slidablyreceives instrumentation retention trays 114-116. As explainedhereafter, the housing 102 is configured to allow the instrumentationretention trays 114-116 to be inserted into and removed from the housing102 in at least three distinct tray access directions. The tray accessdirections are described relative to the longitudinal axis 124 andtransverse axis 144. For example, the three distinct directions may beany combination from the sides 105, 107 and ends 109, 111 of the housing102. In the example of FIG. 1, two intermediate shelves 108, 110 areprovided, although it is recognized that the housing 102 may be formedwith a single intermediate shelf or more than two intermediate shelves,to provide cabinet 100 with different numbers of instrumentationretention trays. For example, the cabinet 100 may be formed to hold onlytwo trays (e.g., 115 and 116), such as by including shelves 106 and 108,and removing shelf 110. Additionally or alternatively, multiple cabinets100 may be stacked on top of one another. For example, 2, 3 or morecabinets 100 may be stacked on one another, where each of the cabinets100 may be formed to include 2, 3 or more trays. Each cabinet 100 in thestack may have the same or a different number of trays. The heights ofvarious cabinets 100 may be varied, such that a first cabinet 100 istaller than a second cabinet 100. Optionally, the shelves 106, 108, 110and trays 114-116 may be formed with different heights. For example, thespace associated with the lowest shelf 106 and tray 114 may have greaterheight than the top shelf 110 and tray 116, or vice versa.

The component layers within the cabinet 100, such as the top plate 104,shelves 106, 108, 110 and instrumentation retention trays 114-116, areformed of a sterilization tolerant material. By way of example only, oneor more of the top plate 104, bottom shelf 106, shelves 108, 110 andinstrumentation retention trays 114-116 may be formed of stainlesssteel, aluminum, or Radel® R material. Optionally, differentcombinations of materials may be utilized. For example, the shelves 106,108, 110 may be formed from aluminum, while the trays 114-116 may beformed from plastic or Radel® R material. Optionally, the componentlayers are FDA compliant for use in gravity or pre-vacuum steam and ETOsterilization. Optionally, the component layers may be compatible withCSR wrap and filtered containers. All of the component layers within thecabinet 100 may be formed of a common material. Alternatively, some ofthe component layers within the cabinet 100 may be formed of onematerial, while other component layers within the cabinet 100 may beformed of another material. For example, the top plate 104 and shelves106, 108, 110 may be formed of stainless steel, while theinstrumentation retention trays 114-116 may be formed of aluminum, andvice versa. As another example, the top plate 104 and shelves 106, 108,110 may be formed of one material, while the instrumentation retentiontrays 114-116 may be formed of another material, and vice versa.Optionally, any one or more of the components may be formed of acombination of materials. Optionally, the sterilization tolerantmaterial(s) used to form the components of the cabinet 100 may also bebiocompatible materials. The top plate 104 and bottom shelf 106 andshelves 108, 110 may be formed in various manners, such as stamp andforming, molding, machining, extrusion and the like. The parts of anyone or more of the top plate 104 and bottom shelf 106 and shelves 108,110 discussed herein may be formed with one another as one monolithicstructure. Optionally, the parts may be manufactured separated andassembled to one another.

Standoffs 112 are positioned at distributed points about a perimeter ofthe housing 102. The standoffs 112 are secured to and separate theintermediate shelves 108, 110, the top plate 104 and bottom shelf 106.The standoffs 112 hold the shelves 106, 108, 110 and top plate 104spaced apart from one another in order to define tray storage areasthere between. In the example of FIG. 1, first and second tray storageareas are provided and have a shape (e.g., height, longitudinal lengthand transverse length) to receive and retain corresponding first andsecond instrumentation retention trays 114-116 in a secure manner.

Returning to FIG. 1A, the standoffs 112 are spaced apart from oneanother about the perimeter of the housing 102 to define tray passagesbetween adjacent standoffs 112. In the present example, the traypassages are located at one or more sides (e.g., front and/or back) andat opposite ends of the housing 102. The tray passages are sized toallow the first instrumentation retention tray 114 to be inserted intoand removed from the housing 102 in multiple directions, includingthrough all three of the one or more sides 105, 107 (e.g., front and/orback) and opposite ends 109, 111 of the housing 102. In addition, thetray passages are positioned and sized to allow the secondinstrumentation retention tray 116 to also be inserted into and removedfrom the housing 102 in multiple directions, including through three ormore of the sides 105, 107 and ends 109, 111 of the housing 102.Additionally or alternatively, the tray passages may be positioned andsized to allow one or both of the first and second instrumentationretention trays 114, 116 to be inserted into and removed from thehousing 102 through four directions including both sides 105, 107 andboth ends 109, 111 of the housing 102. The height of the tray storageareas is substantially similar to a height of the correspondinginstrumentation retention trays 114-116, provided sufficient toleranceis included to allow the trays 114-116 to fully slide in and out of thecabinet 100. The height tolerance is maintained relatively close suchthat, when a tray 114-116 is partially pulled out, the remaining tailsection of the tray 114-116 is held firmly between adjacent shelves 106,108, 110 and/or top plate 104. The tail sections of the tray 114-116forms a base of a cantilevered arm to support and maintain the exposedleading section of the tray 114-116. By way of example, a substantialmajority (e.g., 75-95%) of the trays 114-116 may be pulled outward to anexposed state while a relative small (e.g., 10-5%) tail section formsthe base of the cantilevered arm.

As explained in more detail hereafter, doors 120-123 are provided overthe sides 105, 107 and ends 109, 111 of the housing 102. The doors120-123 slide within rails (described below in more detail) between openand closed positions. The doors may be moved to a partially openposition, as well as entirely removed from the housing 102 and placedelsewhere while a procedure is performed and instruments are beingremoved from and replaced within the cabinet 100. The doors 120-123 maybe formed of the same material as the component layers of the cabinet100. Additionally or alternatively, one or more of the doors 120-123 maybe formed of a transparent material, such as to allow for easyvisualization of labels provided on individual shelves. For example, theend and/or sidewalls of the trays may include labels designating thegeneral nature of the content or listing the individual instrumentstherein. By utilizing transparent doors, a user may easily read thelabels through the doors without opening the doors. Optionally, thedoors 120-123 may include holes (not illustrated) similar to the holesin the trays and shelfs.

The housing 102 includes handles 134, 135 provided on the top plate 104.The handles 134, 135 facilitate carrying of the cabinet 100. Optionally,the handles 134, 135 may be removed entirely, located in other positionsand/or replaced/supplemented with additional handles.

FIG. 2 illustrates a top front perspective view of the cabinet 100 withthe end door 121 (also referred to as a front door) and the end door 123(also referred to as a back door) slid within corresponding rails to apartially open position. The side door 120 has been entirely removed toexpose the tray passages through the corresponding side of the housing102. The instrumentation retention tray 114 has been slid outward alongthe transverse axis 144 from the corresponding tray passage in the side105 of the housing 102 to a fully open position. As illustrated in FIG.2, the instrumentation retention tray 115 is slid outward to a partiallyopen position, although it is recognized that all of the instrumentationretention tray 114-116 may be slid further out until entirely separatedfrom the housing 102. The top plate 104 and bottom shelf 106 includesets of rails provided along the sides 105, 107 and ends 109, 111 of thehousing 102. The rails on the top plate 104 face and align with rails onthe bottom shelf 106. In the example of FIG. 2, top and bottom siderails 130, 131 are labeled and slidably receive the door 121 and allowthe door 121 to be slid between open and closed positions (with apartially open position illustrated in FIG. 2). End door 123 is moved ina similar manner. The top plate 104 to be formed of a transparentmaterial. The top plate 104 may be removable. Optionally, the top plate104 may be provided with a hinge along one or more sides and/or ends toallow the top plate 104 to be pivotally opened for access to the toptray.

In generally, tipping would not occur in most circumstances. Instead, acenter of gravity of the cabinet 100 would remain at a stable point. Forexample, the empty weight of the cabinet 100 may be sufficient to offsetany imbalance created when multiple trays are opened in a commondirection. Additionally or alternatively, the instruments may be loadedin a manner to facilitate balance such as by loading heavier instrumentsin the lower trays or in trays that are typically entirely removed andnot simply pulled out to an open suspended position.

Optionally the doors 120-123 may be used as legs to resist tipping. Thetop and bottom side rails 130, 131 include door retention segments, suchas an outermost segments 142, that cooperate with the door 120. When thedoor 120 is in a partially open position the door 120 forms a leg toresist tipping by the housing 102. For example, the instrumentationretention trays 114, 116 may all be opened to a fully open state fromthe corresponding tray storage area. In the example of FIG. 2, thesegments 142 are located at opposite ends of each rail 130, 131, suchthat regardless of the direction in which the side door 120 is opened, atrailing portion of the side door 120 may be retained within the segment142 to resist tipping of the housing 102 in either direction along thetransverse axis 144. While not separately illustrated in FIG. 2, it isrecognized that the rails along opposite side of the top plate 104 andbottom shelf 106 also include door retention segments similar to thesegments 142. The end doors 121, 123 may be slid in either directionalong the transverse axis 144 within the corresponding rails to exposethe corresponding end of the housing 102. The end doors 121, 123 may beslid along the transverse axis 144 until only a tail portion of the doorremains within the door retention segment of the corresponding rail inorder to resist tipping of the housing 102 in either direction along thetransverse axis 144, such as when one or more instrumentation retentiontrays is partially pulled out through the front or back of the housing102. Optionally, the rails 130, 131 may be manufactured separately fromthe shelfs and then attached to the shelfs through various means.

FIG. 3 illustrates a top front perspective view of the cabinet 100. Thedoors 120-123 has been entirely removed from the corresponding rails inthe top plate 104 and bottom shelf 106 to entirely expose the ends andsides of the housing 102. The instrumentation retention trays 114-116are pulled outward in three opposite directions, namely from oppositeends and one side of the cabinet 100. Each of the trays 114-116 includehandle features 302 provided along each of the side and end walls 138,140. For example, the handle features 302 may be formed as notches orslots cut in the corresponding sidewalls 138, 140. Additionally oralternatively, the handle features 302 may be formed as knobs or otheroffset structures projecting outward from the corresponding wall 138,140. The knobs or offsets may be formed in the walls 130, 140 and/orattached thereto as separate parts.

FIG. 4A illustrates the various component layers of the cabinet 100 inan exploded arrangement. More specifically, FIG. 4A illustrates the topplate 104, bottom shelf 106, shelves 108, 110 and trays 114-116. Theupper instrumentation retention tray 116 is shown positioned upon thecorresponding shelf 110. Next, the discussion of an individual tray willbe described in connection with instrumentation retention tray 114.However, it is recognized that all or at least a portion of the traysmay have a similar structure. The tray 114 includes include a baseplate136 with walls 138 and 140 surrounding the baseplate 136. In the presentexample, the walls 138, 140 substantially entirely surround thebaseplate 136. Optionally, gaps or notches may be formed in the walls138, 140 such that the walls 138, 140 do not necessarily form a solidcontinuous border around the perimeter of the baseplate 136. In thepresent example, the walls 138, 140 have a common height, however it isrecognized that the walls 130, 140 may have different heights or mayhave uneven heights along individual walls. The baseplate 136 and walls138, 140 form an instrumentation storage area configured to receivemultiple surgical instruments. The walls 138, 140 extent upward from thebaseplate 136 to an open upper space representing an openinstrumentation access area to afford easy access to the instrumentswithin the instrumentation retention tray 114.

In the present example, the cabinet 100 is formed with two intermediateshelves 108, 110 to provide areas to retain three instrumentationretention trays 114-116. However, it is recognized that embodiments maybe formed with a single intermediate shelf 108 to provide areas for twoinstrumentation retention trays. As another option, more than twointermediate shelves may be provided to form areas for more than threeinstrumentation retention trays. Also, in the present example, thespacing between the bottom shelf 106, intermediate shelves 108, 110 andtop plate 104 is generally the same. However, optionally the spacingbetween the bottom shelf 106, intermediate shelves 108, 110 and topplate 104 may differ from one another to allow the use of trays havingdifferent heights within an individual cabinet 100. For example, thelowest tray storage area, proximate to the bottom shelf 106, may beformed with a greater height as compared to a height of the top traystorage area, proximate to the top plate 104. By providing a taller traystorage area near the bottom of the cabinet 100, embodiments hereinallow for the bottom instrumentation retention tray to retain larger andpotentially heavier instruments, while the top instrumentation retentiontray retains smaller for lighter instruments, thereby providing a bettercounterbalanced configuration to resist tipping as upper shelves areopened, but not entirely removed.

The bottom shelf 106, shelves 108, 110 and instrumentation retentiontrays 114-116 are formed with a plurality of holes there through toallow passage of a sterilization medium during a sterilization process.For example, an array of holes may be punched through baseplates in eachof the shelves 106, 108, 110 and instrumentation retention trays114-116. Optionally, holes may be provided in the side walls of thetrays and/or doors 120-123. In accordance with some embodiments, thearray of holes may follow a common pattern and spacing throughout all ofthe shelves 106, 108, 110 and instrumentation retention trays 114-116,such that the holes at least partially align with one another in avertical direction 143. It may be desirable for the holes to align withone another in the vertical direction 143 to facilitate transfer of thesterilization medium (e.g., hot air, hot steam, etc.) upward through theentire housing 102 when the sterilization medium is injected under highpressure through the bottom surface of the bottom shelf 106.

FIG. 4B illustrates instrumentation retention trays with instrumentationalignment features mounted therein in accordance with embodimentsherein. For example, the instrumentation retention trays 115, 116 areillustrated to include instrumentation alignment features 402. As oneexample, the instrumentation alignment features 402 may be mounted tothe tray base by friction fitting post through one or more of the holesstamped in the tray bases. As another example, the instrumentationalignment features 402 may be adhesively secured to, or molded with, thetray base. As a further example, the instrumentation alignment features402 may be formed monolithically within the tray base, such as bystamping or otherwise shaping the tray base to include indentationsdefining patterns corresponding to specific instruments.

As one example, the instrumentation alignment features 402 may include apair of opposed ribs 404 that are aligned to extend parallel to oneanother and are spaced apart to define an instrumentation inset 404therebetween. Optionally, an end rib 406 may extend perpendicular to orat another select angle with respect to the ribs 404. The end rib 406 isspaced apart from the opposed ribs 404, such that the collection of endand opposed ribs 406, 404 define a generally T-shaped instrumentationinset 404. In the present example, the ribs 404, 406 are mounted to thetray base through posts that are pushed through one or more of the holesin the tray base and held therein in a frictional manner or withsnapping features on distal ends of the post once pressed throughcorresponding holes. It is recognized that numerous combinations ofinstrumentation alignment features 402 may be provided based on thenature, shape and size of the instruments to be retained within thecorresponding instrumentation retention tray 115, 116. The ribs 404, 406may be removed and reset in various patterns, such as when it isdesirable to reconfigure an instrumentation retention tray to receive adifferent combination of instruments for a subsequent procedure.

Optionally, the instrumentation alignment features may be molded with orstamped into the tray base, wherein such features will similarly have ashape that defines instrumentation insets corresponding to theparticular types of tools to be held in the instrumentation retentiontray 115, 116. For example, when Radel® material is used,instrumentation insets may be molded directly into the top surface ofthe tray base, where each instrumentation inset is shaped to correspondto a desired instrument. Further, the use of Radel® material to form thetrays allows for a lighter overall tray structure. Optionally, theinstrumentation inset 404 may be colored or provided with other indiciathat generally indicates an outline of the instrumentation to bereceived therein. For example, when the instrumentation inset 404 isintended to receive a hammer, a portion of the tray base may be coloredwith a pattern corresponding to the shape of the hammer and provided inthe region intended to receive the hammer.

Next, FIGS. 5A and 5B are discussed in connection with an exampleembodiment for a standoff to define heights of the tray storage areas.FIG. 5A illustrates an enlarged perspective in view of a corner of thehousing 102 formed in accordance with embodiments herein. FIG. 5Billustrates an enlarged perspective view of the corner of the bottomshelf 106. It should be recognized that, while the following discussionmay primarily refer to the bottom shelf 106, the top plate 104 andbottom shelf 106 and shelves 108, 110 may include all or a portion ofthe same features.

FIG. 5A illustrates a corner of the housing 102 with the standoff 112 ina partially disassembled state in accordance with embodiments herein.The top plate 104, bottom shelf 106 and shelves 108, 110 are arranged inan assembled position. A tray storage area 165 is provided between thebottom shelf 106 and the next adjacent shelf 108, while a tray storagearea 166 is formed between the adjacent intermediate shelves 108, 110.The bottom shelf 106 includes a baseplate 136 having an upper surface168 that faces a lower surface 170 of the adjacent intermediate shelf108. The upper surface 168 of the baseplate 136 is spaced a height 164from the lower surface 170 of the shelf 108. The height 164 correspondsto a height of the tray storage area 165. Similarly, an upper surface ofthe shelf 108 is spaced a height 167 from the lower surface of theadjacent shelf 110, where the height 167 corresponds to a height of thetray storage area 166.

In accordance with some embodiments, it may be desirable to maintain arelatively close tolerance between the heights 164, 167, etc. of thetray storage areas and a height of the walls on the instrumentationretention trays to hold the trays stable in an open position/state. Forexample, a relatively close tolerance may be desirable to avoidinstrumentation from inadvertently falling out of a tray when thecabinet is moved (e.g., tipped, turned upside down, laid on a side,etc.) As another example, it may be desirable to maintain a closetolerance between the heights 164, 167 and the wall height in order thatthe shelfs support the instrumentation retention trays in asubstantially horizontal orientation even when the instrumentationretention trays are opened to a fully open position/state. Moregenerally, the close tolerance between the heights 164, 167 and the wallheight maintains the instrumentation retention trays aligned alongplanes that correspond to associated planes of the supporting shelves.As noted herein, feet may be provided on the bottom surface of thetrays, in which case, the height of the tray would extend from thebottom of the feet to the top of the highest point, such as the top edgeof the side and end walls.

The heights of the tray storage areas 165, 166, etc. are defined by thestandoff 112. The standoff 112 may be formed from two parts, namely abracket connector 158 and a series of tabs 160-163 that align anddirectly stack upon on one another when the top plate 104, bottom shelf106 and shelves 108, 110 are arranged in an assembled position. The tab161 is formed with the baseplate 136 and is located proximate to acorner of the baseplate and is bent downward to extend outward in adirection transverse from a plane of the baseplate. By way of example,the tab 161 may be bent to form an approximate 90° angle with respect tothe surface of the baseplate. Optionally, the tab 161 may be bent toextend at an obtuse or acute angle to the baseplate. Similarly, the tabs160 and 162 may be formed in a similar manner and bent to extend in adesired direction transverse to the corresponding shelf or top plate 104such that the tabs 160-163 align with, directly about against and stackupon one another. Optionally, the all or a portion of the tabs 160-163may be bent upward to extend in a direction opposite to the directionillustrates. Optionally, a portion of the tabs 160-163 may be bentupward, while another portion of the tabs 160-163 are bent downward.

The tab 161 has a height 152 that may be utilized to define the height164 of the tray storage area 166. For example, the tab 161 may includean engagement surface that directly engages a corresponding engagementsurface on tab 160 at interface 154. An engagement surface of the tab162 directly engages a corresponding engagement surface on tab 161 todefine the height 167 of the tray storage area 166. The tabs 160-163 areshown to include holes 156 that align with holes in the bracketconnector 158 when the bracket connector 158 is mounted to the tabs160-163. The bracket connector 158 is secured to the tabs 160-163, suchas through bolts, rivets, welds and the like.

Optionally, one or more combinations of the adjacent tabs 160-163 may bespaced apart from one another when secured to the bracket connector 158.For example, the bottom and intermediate shelves 106, 108 may be spacedfurther apart by separating the tabs 160, 161 and securing the tabs 160,161 to a combination of holes through the bracket connector 158 that arespaced apart. In the foregoing manner, the bracket connector 158 affordsflexibility to adjust heights of individual tray storage areas.Optionally, the height of tray storage areas may be adjusted byadjusting the length of the corresponding tab 160-163.

Optionally, the bracket connector 158 may be removed entirely and thetabs 160-163 joined in other manners, such as adhesive, welding and thelike to form the standoff 112. Optionally, the tabs 160-163 may beomitted entirely and the bracket connect 158 may be used to holdadjacent shelfs apart from one another by a desired distance.Optionally, additional components may be included in addition to or inplace of the bracket connector 158 and/or the tabs 160-163. For example,a spacer (e.g., straight, U-shaped, C-shaped etc.) may be insertedbetween adjacent shelfs at desired points to define the distance betweenadjacent shelfs. It is recognized that any portion of the foregoingexamples constitute standoffs, as well as other alternative structures.

It should be recognized that portions of the intermediate shelves 108,110 have been removed to better illustrate the above discussed featuresin connection with FIG. 5A. The intermediate shelves 108, 110 alsoinclude side walls and end walls 138, 140 as discussed herein.

FIG. 5B better illustrates a corner segment of the bottom shelf 106 inaccordance with embodiments herein. As explained above, the bottom shelf106 includes a baseplate 136 that is a generally planar layer ofmaterial. The baseplate 136 includes an array of holes 148 punched therethrough in a pattern that substantially conforms to the array of holesin the other shelfs and instrumentation retention trays in the cabinet100. The bottom shelf 106 includes a rail 131 extending along alongitudinal edge thereof and a rail 133 extending along a transverseedge thereof. The rails 131, 133 may be formed with the baseplate 136,such as through a stamp informing operation, as well as through otherknown machining processes. The rail 131 includes a groove 137 having anopen end that is configured to slidably receive a corresponding door,such as the side door 120 (FIG. 1A).

FIGS. 5C and 5D illustrate front and rear perspective views of a cornerconnector formed in accordance with an alternative embodiment. Thecorner connector 502 includes a curved bracket 504 is bent atapproximately a 90° angle. The bracket 504 sits on a corner portion ofthe bottom shelf at 506, while a corner portion of the top shelf is heldwithin the bracket 502. The bracket 502 further includes a shelf spacer508 having a next to rear surfers that is curved to fit against aninterior surface of the bracket 504. The shelf spacer 508 may be formedas multiple separate spacers that are fit between the shelves, were theheights of the spacers define the height between adjacent shells.Alternatively, the shelf spacer 508 may be formed as one continuousmonolithic piece with a series of notches formed therein, or the notchesare configured to receive corner portions of corresponding shelves. Thespacing between the notches defines the height between adjacent shells.A securing mechanism 510, such as a screw may be threaded down throughthe bracket to secure the shelves to the corner connector 502. Forexample, a threaded bolt or screw may be fitted through aligned holeswithin the shelf spacer 508 and corresponding holes in corner portionsof each of the shelves. A top plate 512 may be pressed downward by thesecuring mechanism 510 to compress down upon the corner portion of thetop shelf. Optionally, the top plate 512 may be omitted and the cornerportion of the top shelf used in place thereof.

The embodiment of FIGS. 5A and 5B may provide a more efficient designthat reduces the overall envelope of the corner portion, therebyallowing the instrumentation retention trays to be made larger, and havea size only slightly smaller than the overall envelope of the cabinet.

FIG. 6 illustrates a portion of the cabinet 100 while loaded into achamber 602 configured to perform a sterilization process. Theillustrated portion of the cabinet 100 may include a portion of thebottom shelf 106, tray 114, intermediate shelf 108 and tray 115. Thetrays 114 and 115 rest upon the corresponding bottom and intermediateshelves 106, 108. FIG. 6 illustrates a portion of the baseplate 136 ofthe bottom shelf 106, including a portion of the array of holes 148through the baseplate 136. The trays 114-115 include tray baseplates114A and 115A, respectively, that include an array of holes 114B and115B there through. As shown in FIG. 6, the holes 114B and the traybaseplate 114A at least partially align with the holes 148 in thebaseplate 136 of the bottom shelf 106. The holes 115B in the traybaseplate 115A of the intermediate tray 115 do not overlap with theholes 148 in the intermediate shelf 108.

Bottom surfaces of the trays 114, 115 include feet 114C and 115C,respectively. The feet 114C, 115C may be formed in various manners, suchas molded into or mechanically attached to the underside of the trays114, 115. The feet 114C, 115C may be located in various locations on thetrays 114, 115 to allow the trays 114, 115 to rise off the shelves andcreate a space therebetween. For example, the feet 114C, 115C may beformed from the tray baseplates 114A, 115A such as by pressing indentsor dimples in the tray baseplates 114A, 115A. Optionally, the feet 114C,115C may represent screws, tabs or other structures that are attached tothe bottom surface of the corresponding tray 114, 115 and the like.Optionally, feet 114C, 115C may be formed in or provided on the uppersurface of the baseplates of the shelves 106, 108. The feet 114C, 115Care configured to maintain a space between the trays 114, 115 andshelves 106, 108 in order to define air passages 174 and 176. The feet114C on the tray 114 maintain the air passages 174 between a bottomsurface of the tray baseplate 114A and an upper surface of the bottomshelf 106. The feet 115C maintain the air passages 176 between a bottomsurface of the tray 115 and an upper surface of the intermediate shelf108. The air passage 174, 176 facilitates the sterilization process, aswell as a space for the underside of the instrumentation brackets toextend though the tray base. The air passages 174, 176 enable asterilization medium to pass through the holes 148, 114B and 115B, aswell as to pass along and substantially encompass each and every surfaceof the bottom and intermediate shelves 106, 108 as well as each andevery surface of the trays 114, 115. In addition, the air passages 174,176 enable the surfaces of the shelves 106, 108 and trays 114, 115 todry after completion of a sterilization process to avoid “wet pack”.

Optionally, the feet 114C, 115C may be formed form silicon to providesome grip or tension between the tray 114, 115 and the shelves for morecontrol when pulling out the trays 114, 115 partially. The feet 114C,115C also serve the purpose of keeping the trays from being too loosewhile housed in the shelving. The feet may be provided at the corners ofthe tray base and/or distributed through out the tray base, such as toavoid the outer edge of the tray from dropping when initially pulled outby an amount sufficient for the first two feet to clear the shelf.

Additionally or alternatively, instrumentation retention brackets may beattached to the baseplates 114A, 115A of the trays 114, 115, wherein theinstrumentation retention brackets are configured to retaininstrumentation within a corresponding tray. The instrumentationretention brackets may be inserted through the holes 148 to be securedto the baseplates 114A, 115A. Additionally or alternatively, theinstrumentation retention brackets may be inserted through additionalslots or separate openings formed through the baseplates of the trays tosecure the instrumentation retention brackets in place. The distalportions of the instrumentation retention brackets that extend throughthe baseplate 114A, 115A, may be used in addition to or in place of thefeet 114C, 115C to define the air passages 174, 176.

A sterilization medium source 604 provides a sterilization medium to thechamber 602. Various types of medium may be used during thesterilization process, such as heated air, steam, liquid or vaporchemicals and the like. The sterilization medium travels through thechamber 602 in a predetermined direction and/or multiple randomdirections. For example, the chamber may include an inlet 606 throughwhich the sterilization medium is introduced and one or more outlets 608through which the sterilization medium is discharged. For example,heated and pressurized error or steam may be passed through one or moreinlet 606 and discharged from one or more outlets 608. The sterilizationmedium propagates through any and all interior passages within thecabinet 100 in order to sterilize all surfaces of the cabinet 100. InFIG. 6, a series of paths are denoted by arrows 610 to illustrate themanner in which the sterilization medium is allowed to touchsubstantially every upper and lower surface of the shelves 106, 108 andtrays 114, 115, as well as all other layered components and structuresof the cabinet 100.

While the pattern of holes 148, 114B and 115B are illustrated to besubstantially similar to one another, optionally, different holepatterns may be provided in different shelves 106, 108 and/or differenttrays 114, 115. The alignment between the holes 148 in the shelves 106,108 and the holes 114B, 115B may vary as the trays 114, 115 maylaterally shift in the longitudinal and transverse directions (e.g. 124,144 in FIG. 1A) relative to the shelves 106, 108 while maintained in astorage position.

Optionally, the cabinet may be inserted and stored into a closed rigidouter container (e.g., an Asculap container). Optionally, the cabinetmay be wrapped in disposable, single-use wrap (e.g., Chemguard wrap,sterilization wrap products by Medline or other companies).

FIG. 7 illustrates a side perspective view of an intermediate shelf 108and a tray 115 configured to cooperate with one another. The tray 115has sidewalls 192 and end walls 194 that extend upward from the traybase 196 to define an instrumentation storage area there between. Forexample, the side and end walls 192, 194 may be formed with the traybase 196 and bent in a desired direction to form the instrumentationstorage area. Additionally or alternatively, one or more of thesidewalls and end walls 192, 194 may be formed separately and assembledwith the tray base 196. One or more of the side and end walls 192, 194may include gripping elements 198 that enable a user to easily grasp ofthe tray 115 when the tray is in a tray storage position within thecabinet 100. The gripping elements 198 may be formed as indents pressedinto the corresponding side or end walls 192, 194. Optionally, thegripping elements 198 may be mounted to the side or end walls 192, 194.The tray 115 may have a length 187 and a width 188.

In the example of FIG. 7, the sidewalls 192 and end walls 194 generallyintersect at an approximately square corner. Optionally, the tray 115(and any/all other trays) may be formed with beveled corners.

The shelf 108 includes a baseplate 180 that has tray retention fins 177,178 that extend upward therefrom. The tray retention fins 177 and 178are positioned proximate to side edges 182 and end edges 184,respectively, of the baseplate 180. The tray retention fins 177 and 178define a length and width of a tray storage area, and cooperate tomaintain the tray 115 in a relatively fixed position when in the traystorage area. The tray retention fins 178 proximate to the end edges 184are spaced apart from one another at opposite ends by a distancesubstantially similar to a longitudinal length 187 of the tray 115. Thetray retention fins 177 proximate to the side edges 182 are spaced apartfrom one another at opposite sides by a distance substantially similarto a width 188 of the tray 115. The tray retention fins 177, 178 preventthe tray 115 from inadvertently slighting out of a tray storage area.

To remove the tray 115 from the corresponding tray storage area, a usergrasp a side or end of the tray (depending upon the direction in whichthe user desires to pull out the tray). The user lifts up slightly toraise the end or side of the tray 115 up and over the corresponding trayretention fin 177, 178, while pulling outward (and/or pushing on anopposite end/side) of the tray 115 until the leading edge of the tray115 crossed over the corresponding tray retention fins 177, 178.Thereafter, as the tray 115 is further slid from the tray storage area,a bottom surface of the tray 115 slides along the top of thecorresponding fin 177, 178.

FIG. 8 illustrates a top front perspective view of a cabinet 800 with ahousing 802 that includes more than two intermediate shelves. Thecabinet 800 holds at least five trays 814-818, with trays 814-815 openedfrom the front and back sides and the trays 816-817 opened from theends. A top plate 804 is formed with an opening 821 therein. The opening821 may be covered with a clear material to allow content of the tray tobe visible. Optionally, the opening 821 may be closed and opened with alid (solid or transparent).

FIG. 9A illustrates a top plan view of a tray 915 formed in accordancewith an embodiment herein. The tray 915 includes a tray base 996 that isjoined to sidewalls 992 and end walls 994 (that project out of thesheet). The tray base 996 is formed with straight beveled corners 995 toavoid the corners catching as the trays are lid in and out in thevarious directions. As one non-limiting example, the beveled corners 995may be beveled at an angle between 5-15 degrees. Optionally, the corners995 may have vertical walls bent upward similar to the sidewalls 192and/or end walls 194. Optionally, instead of straight edges, the beveledcorners 995 may be rounded to form a radius or chamfer bevel (as notedby dashed line 995A) that transitions between the side and end walls992, 994. Optionally, the beveled corners 995 may be formed with aseries of straight angles, such as along an edge of a hexagon, octagonor other multi-sided polygon.

Next, the discussion turns to an alternative configuration for the topplate (e.g. top plate 104) and a manner in which the top plate ispivotally and removably attached to the cabinet.

FIG. 9B illustrates an end view of a top plate hinge assembly 950 thatmay be mounted on a top of a cabinet housing in accordance withembodiments herein. The hinge assembly 950 includes a base 952configured to be mounted on a top of the housing of the cabinet (e.g. at951). The hinge assembly 950 further includes a stem 954 pivotallymounted to the base 952, such as at hinge 956. The hinge 956 allows thestem 954 to rotate in the directions noted by arrow 958. The stem 954includes a top plate retention cavity 960 that is configured to receivean edge of a top plate 904. The retention cavity 960 securely retainsthe top plate 904, such that as the stem 956 rotates about arrow 958,the top plate 904 similarly rotates in the direction of arrow 958between a closed position (as illustrated in FIG. 9C) and an openposition. By way of example, when the top plate is in the open position,the top plate 904 may be extending vertically upward in an air directionof arrow 962. The hinge 956 may be biased to maintain the top plate 904in a select number of positions, such as in a horizontal closed position(e.g. as illustrated in FIG. 9B), in a vertical fully open position(e.g. when the top plate 904 is oriented to extend in the direction ofarrow 962) and any intermediate point there between. Optionally, thehinge 956 may allow the top plate 904 two pivot beyond a verticalposition (e.g. beyond 90° from the position illustrated in FIG. 9B). Thehinge 956 may be configured to maintain the top plate 904 at discreteorientations with respect to the horizontal top surface of the housing(951), in order that a medical personnel need merely partially lift thetop plate, in response to which the top plate 904 will move upward tothe predetermined discrete angle with respect to horizontal (e.g. 45°,90°, 135°, 180°). Optionally, the hinge 956 may be configured tomaintain the top plate 904 at any position along a 180° arc, such thatthe user merely need lift the top plate 904 two any desired position.When the user releases the top plate 904, the hinge 956 will maintainthe top plate 904 at the position where released.

FIG. 9C illustrates a top plan view of the top plate hinge assembly ofFIG. 9B, when mounted to a housing of a cabinet in accordance withembodiments herein. The cabinet 900 includes a housing 902 that has arear side 907 and an end 909. The top of the housing 902 includes aperipheral edge 903, 905 that extends about the rear side 907 and theend 909. The hinge assembly 950 is mounted along the peripheral edge903, but optionally may be mounted along the peripheral edge 905. FIG.9C illustrates the top plate 904 and a closed position against theperipheral edges 903, 905 of the housing of the cabinet. The hingeassembly 950 allows the top plate 904 to be rotated upward out of thepage in FIG. 9C. The top plate 104 may be removable from the hingeassembly 950. For example, the top plate 904 may be slid in thedirection of arrow 972 remove the top plate 904 from either end of theretention cavity 960 (FIG. 9B) in the stem 954. For example, during aprocedure, the top plate 904 may remain closed until a correspondingstage of the procedure in which instrumentation within the retentiontray immediately below the top plate 904 is needed. When the instrumentsin the retention tray below the top plate 904 are needed, the top plate904 may be pivoted upward (along arrow 958) to expose an open top in thehousing and to provide access to the upper instrument retention tray.Additionally or alternatively, the top plate 904 may be slid along arrow972 to be removed from either end of the stem 954 and retention cavity960.

FIG. 10 illustrates a corner perspective view of a pair of cabinetsnested with one another in accordance with an embodiment herein. FIG. 10illustrates first and second cabinets 1002, 1004 there stacked upon oneanother in a nested vertical manner. Each of the cabinets 1002, 1004include multiple shelves and trays in various combinations as describedherein. The cabinets 1002, 1004 are joined together by a cabinet linkingmember 1006. For example, the cabinet linking member 1006 may be aflexible strap, such as a silicon strap having holes therethrough thatmay be secured over posts (e.g. post 1008, 1010) provided along thecorner brackets of the corresponding cabinets 1002, 1004. FIG. 10Aillustrates a cabinet linking member 1006 secured to post 1008, 1010provided on respective brackets 1012, 1014. The cabinet linking member1006 is elastic, thereby maintaining a continuous tension pulling theupper cabinet 1004 downward onto the lower cabinet 1002. In the presentexample, a cabinet linking member 1006 is provided at each corner tosecure all four corners of the cabinets 1002, 1004 to one another.Optionally, the cabinet linking members 1006 may be provided inalternative positions and in alternative amounts. For example, more thanone cabinet linking member may be provided at any individual corner,while one or more of the corners made not include any cabinet linkingmembers. Optionally, the cabinet linking members may be formed ofanother material, other than a silicon strap.

As a further example, the straps may be formed through molding or adiecut and made of a medical grade silicone that would attach to flangedprotrusions extending from the top and/or bottom of the cornerconnectors. The protrusions could be formed as a hook or button that isformed or molded into the corner connector. Optionally, the protrusioncould represent a screw or other part that is attached to the cornerconnector. The strap is manually stretched over the hooks, buttons orother protrusions located near the bottom of one corner connector andthe top of another corner connector. Optionally, the straps could havesufficient strength to enable a group of cabinets to be picked up andmoved in combination by simply hanging onto the handles on the topcabinet.

Optionally, in accordance with embodiments herein, one or more cabinetsmay be provided with trays containing instrumentation organized inconnection with particular procedures. For example, a procedure mayrepresent a thoracolumbar, cervical or interbody anterior or posterioropen or minimal invasive spinal fusion procedure. For example, the firsttray may correspond to a screw preparation tray. As one example, thescrew preparation tray may include gear shifts, taps, sounders,screwdrivers, handles, screw gauges, and the like. As another example,the second tray may correspond to a rod manipulation/insertion tray,which may include benders, screwdrivers, counter torques, rod grippers,rod pushers, rods, rod reducers and the like. The third tray maycorrespond to a miscellaneous instrumentation tray or an implant trayhousing the desired surgical screws corresponding to the particular typeof procedure. It is recognized that the foregoing example is only onenon-limiting example. Other non-limiting examples of procedures includecervical procedures and the like.

As non-limiting examples, many types of surgeries can be organized intostages of surgery. Optionally, a surgery may be organized into twostages, three stages, four stages or more stages. One type of pediatricsurgery is an AIS (Adolescent Idiopathic Scoliosis). For example, an AISsurgery may operate on various vertebrae, such as the T3-L3 vertebrae,with the T3 representing the 3^(rd) vertebrae in the thoracic spine andspanning down to L3 which is the 3^(rd) vertebrae in the Lumbar spineetc. As another example, the surgical procedure may involve an AdultPosterior Spinal Fusion, for which example levels range from T10-sacrumand pelvis or even larger cases that are instrumented T2-sacrum andpelvis. Another example of a surgical procedure would be a degenerativelumbar procedure which would not span as many levels as mentionedpreviously, but instead the degenerative lumbar procedure focuses onfewer levels such as a L2/3-L5 or a L2-sacrum and pelvis instrumentedposterior fusion. Obviously there are many type of procedures. Also, theprocedures may approach the spine in different manners, such as anteriorand posterior cervical fusions and anterior, posterior, MIS (MinimalInvasive Surgery), or a combination of these approaches for a variety ofsurgeries etc. The foregoing are non-limiting examples of procedures.Embodiments herein may be utilized with many different specialties inaddition to spine including ENT, cardio thoracic, plastic, eye etc. andoffers many potential benefits to include, but not limited to, timesavings, cost savings, safety, flexibility, and potential contaminationbenefits.

An overall procedure may utilize an overall procedure set ofinstruments. The surgical procedure may be separated into 2, 3 or morestages. Each stage of the surgical procedure utilizes a subset orcollection of instruments from the overall set of instruments. Some orall of the instruments in a predetermined subset or collection ofinstruments may be used during a corresponding stage. The collection ofinstruments that may be utilized in a particular stage of a proceduremay also be referred to herein as stage-specific instruments (e.g.,stage-1 instruments, stage-2 instruments, exposure stage instruments,rod manipulation stage instruments, and the like). More generally, aprocedure may be divided into first, second, and third stages (andoptionally more stages). The overall procedure set of instruments thatis divided into first, second and third (and optionally more) subsets orcollections of instruments are configured to be used in thecorresponding first, second and third stages of the procedure. The firstsubset or collection of instruments is configured to be utilized inconnection with particular tasks or actions taken during the firststage. The second subset or collection of instruments is configured tobe utilized in connection with particular tasks or actions taken duringthe second stage. The third subset or collection of instruments isconfigured to be utilized in connection with particular tasks or actionstaken during the third stage.

In accordance with embodiments herein, sets of cabinets may be organizedand combined in connection with specific surgical procedures, where oneor more cabinets from the set of cabinets may be assigned or dedicatedto each stage of the surgical procedure. For example, a first cabinetmay be assigned to a first stage, while second and third cabinets areassigned to second and third stages, respectively. Additionally oralternatively, a subset of two or more cabinets may be assigned to oneof the stages, while a same number of cabinets, fewer or more cabinetsmay be assigned to other stages. For example, a subset of two or morecabinets may be assigned to the first stage, a single second cabinet maybe assigned to the second stage, two or more cabinets may be assigned tothe third stage, and a single fourth cabinet may be assigned to thefourth stage. When a cabinet is described to be “assigned” or“dedicated” to a stage, the cabinet includes only instruments to be usedin the corresponding stage. By way of example, the instruments in a rodmanipulation stage cabinet are only to be used in the rod manipulationstage of the procedure and are not to be used in the exposure stage orscrew insertion stage.

For example, a spine surgery may be broken into three main stages,namely i) exposure stage, ii) screw insertion stage and iii) rodmanipulation and closure stage. The exposure stage includes a series of“set up” tasks, which include the tasks performed and time spent bymedical personnel in an O.R. room prior to a patient entering the room.Among other things, one of the tasks performed during the set up processis for medical personnel to bring the cabinets and surgical trays intothe O.R. and position and arrange the cabinets on various tables andother supports in a desired arrangement about the O.R. in connectionwith preparing for the procedure. The set up tasks take a set up time tobe performed. While different types of surgeries have different set uptasks and set up times, in generally most procedures will require a setup time of at least 30 minutes, and more generally 30-45 minutes.

The exposure stage also includes a series of “patient preparation”tasks, which include bring a patient into the O.R., moving the patientonto an O.R. table, and performing final preparation of the patient forthe surgical procedure. The preparation tasks take a preparation time tobe performed. While different types of surgeries have different patientpreparation tasks and preparation times, in generally most procedureswill require a preparation time of at least 20 minutes, and moregenerally 20-30 minutes.

In accordance with embodiments herein, the instruments in the cabinetsremains enclosed and sheltered within corresponding trays and cabinetsfor an entirety of the setup and preparation tasks, which may range from50 minutes, to 50-75 minutes or more.

Next, the exposure stage includes a series of exposure tasks to expose aportion of interest for the surgical procedure. The exposure tasks takean exposure time to be performed which can take over 30 minutes and moregenerally anywhere from 30-60 minutes. In accordance with embodimentsherein, the instrumentation in the cabinets, that is unrelated toexposure tasks, remains enclosed and sheltered within correspondingtrays and cabinets for an entirety of, not only the setup andpreparation stages of the surgical procedure, but also the exposurestage, thereby maintaining the non-exposure related instrumentation(e.g., screw insertion instrumentation and rod manipulationinstrumentation) in an enclosed and sheltered environment for at least80 minutes and more generally for 80-135 minutes or more than 135minutes for longer exposure stages.

The screw insertion stage includes a series of screw insertion tasksassociated with placing pedicle screws into the vertebral bodies. Thescrew insertion tasks may vary in screw insertion time and scopedepending on the type of procedure and number of instrumented levels.For example, a posterior fusion type of screw insertion task may involveestablishing 20 fixation points, which may take more than 60 minutes toperform and typically 60-90 minutes.

In accordance with embodiments herein, the instrumentation in thecabinets, that is unrelated to exposure or screw insertion tasks,remains enclosed and sheltered within corresponding trays and cabinetsfor an entirety of, not only the entire exposure stage of the surgicalprocedure, but also the screw insertion stage, thereby maintaining thenon-exposure and non-screw insertion related instrumentation in anenclosed and sheltered environment for at least 140 minutes and moregenerally for 140-225 minutes or more than 225 minutes for longerexposure and/or screw insertion stages.

The rod manipulation and closure stage include a series of rodmanipulation and closure tasks including inserting the rods into thescrew fixation points, attaching set screws, and using a variety ofinstruments to manipulate the rod and apply a spine adjustment ofinterest (e.g., correct the spine). The rod manipulation tasks alsoinclude final tightening and break-off of set screws which is performedbefore last steps of decortication and bone grafting before the finalincision closure tasks. The rod manipulation and closure tasks areperformed over a rod manipulation and closure time. By way of example,the rod manipulation and closure time may be at least 60 minutes andtypically takes approximately 60-90 minutes depending on the size andscope of the procedure.

Thus, as explained herein, the rod manipulation and closureinstrumentation in the cabinets, remains in an enclosed and shelteredstate within corresponding trays and cabinets for an entirety of, notonly the entire exposure stage of the surgical procedure, but also thescrew insertion stage, thereby maintaining the rod manipulation andclosure related instrumentation in an enclosed and sheltered state andenvironment for at least 140 minutes and more generally for 140-225minutes or more than 225 minutes for longer exposure and/or screwinsertion stages. The rod manipulation and closure relatedinstrumentation is only exposed to the O.R. environment during thecorresponding stage of the procedure, namely up to 60-90 minutes beforebeing utilized. In the foregoing example, a total time estimate for a 10level fusion is 315 minutes, namely five hours and twenty five minutes.

FIG. 11 illustrates a process for organizing a cabinet system to beutilized in a multi-stage surgical procedure in accordance withembodiments herein. In the example of FIG. 11, the multi-stage surgicalprocedure includes three stages, such as discussed above, namely i)exposure stage, ii) screw insertion (SI) stage and iii) rod manipulationand closure (RMC) stage. At 1102, a set of instruments for the surgicalprocedure are divided into subsets or collections associated with thecorresponding stage.

At 1104, a collection of cabinets are selected and designated for thecorresponding stages. For example, the selection may include choosingcabinets that have a desired number of shelves (levels) to receive adesired number of trays. In the present example, a collection (e.g., 3)of two-level cabinets are chosen, where each of the two-level cabinetshave a top plate, a bottom shelf and one intermediate shelf therebetween, to define first and second tray passages that are configured toreceive first and second instrumentation retention trays, respectively.The tray passages allow both of the first and second instrumentationretention trays to be inserted into the housing, opened to an openposition relative to the housing, and/or entirely removed in at leasttwo directions, and more preferably at least three directions. Thecollection of cabinets may include 3 two-level cabinets, where each ofthe three cabinets are assigned and dedicated to be used with acorresponding one of the 3 stages (referred to herein as stage-#cabinet, exposure stage cabinet, etc.).

At 1106, a stage-1 (exposure stage) cabinet is provided that is loadedwith instrumentation associated with actions and tasks performed duringthe exposure stage. For example, the stage-1 cabinet is a 2-levelcabinet that includes two wire baskets as the instrumentation trays. Thetray passages in the stage-1 cabinet are positioned to allow theinstrumentation retention trays therein to be inserted into the housingand opened to an open position relative to the housing through at leastone end and at least one side. The two wire baskets are loaded withexposure instruments. For example, the instruments may includeosteotomes, pituitarys, rongers, kerrisons, needle driers, mallet. Oneor more labels may be inserted on one or more side or end walls of thetray and/or on the cabinet housing. The exposure trays may be labeled,such as “Stage 1”, “Exposure Stage”, “Exposure Instrumentation Tray #1”,“Exposure Instrumentation Tray #2”, and the like. Additionally oralternatively, the exposure trays may be color coded. Additionally oralternatively, the exposure trays and/or cabinet may be labeled with alist of the instrumentation provide therein.

At 1108, a stage-2 (screw insertion stage) cabinet is provided that isloaded with instrumentation associated with actions and tasks performedduring the screw insertion stage. For example, the stage-2 cabinet is a2-level cabinet that includes two instrumentation trays. The traypassages in the stage-2 cabinet are positioned to allow theinstrumentation retention trays therein to be inserted into the housingand opened to an open position relative to the housing through at leastone end and at least one side. The two trays are loaded with screwinsertion instruments. For example, the instruments in one tray (onelevel) may include gear shifts, sounders, taps, screw drivers, powerhandpiece. The instruments in the second tray (second level) may includescrews having select diameters (e.g., 5.5, 6.0, 6.5, and 7.5) and selectlengths (e.g., 30-55 mm), as well as rods and set screws. The trays maybe labeled (e.g., Stage 2, Set Screw Stage, Screw Insertion Tray #1,Screw and Rod Implant Tray #2). One or more labels may be inserted onone or more side or end walls of the tray and/or on the cabinet housing.

At 1110, a stage-3 (rod manipulation and closure stage) cabinet isprovided that is loaded with instrumentation associated with actions andtasks performed during the rod manipulation and closure stage. Forexample, the stage-3 cabinet is a 2-level cabinet that includes twoinstrumentation trays. The two trays are loaded with rod manipulationand closure instruments. For example, the instruments in one tray (onelevel) may include a French bender, distractor, compressor, rod pusher,rod grippers, stab and grab, rachet handles, kyphosis and lordosisbenders, rocker, blue t-handles, swisel sticks and breakoff countertorque. The second tray (second level) may include any othermiscellaneous instruments potentially needed. The trays may be labeled(e.g., Stage 3, Rod Manipulation Stage, Rod Manipulation Tray #1,Miscellaneous Instruments Tray #2). One or more labels may be insertedon one or more side or end walls of the tray and/or on the cabinethousing.

Optionally, the providing operations at 1106-1110 may includepositioning the cabinets in the O.R., such as by stacking the cabinetson one another and/or arranging the cabinets adjacent one another in aspaced apart manner, and/or a combination thereof (e.g., stacking 2cabinets and setting a 3^(rd) cabinet at a spaced apart location).

Optionally, the tray passages in the stage-1, stage-2 and/or stage-3cabinets are positioned to allow the instrumentation retention traystherein to be inserted into the corresponding housings and opened to anopen position relative to the corresponding housings through at leastthree directions.

At 1112, the method utilizes the collection of multi-level cabinetsduring the surgical procedure. The utilization operation includesopening the instrument retention trays of the stage-1 cabinet during thefirst stage in one of at least two directions, while maintaining theinstrument retention trays of the stage-2 cabinet closed during thefirst stage. For example, the at least two directions may include atleast one end and at least one side of the housing. The utilizationoperation further includes maintaining the instrument retention trays ofthe stage-1 and stage-2 cabinets closed until one or more of theinstruments in a corresponding one of the instrument retention trays isneeded for use in the surgical procedure to reduce a potential forcontamination. By way of example, the surgical procedure includes anexposure stage, a screw insertion stage and a rod manipulation stage.The multi-level cabinets include at least one instrument retention traythat includes rod manipulation instruments for use during the rodmanipulation stage. The utilization operation comprises maintaining theat least one instrument retention tray, that includes the rodmanipulation instruments, in a closed and sheltered environment withinthe corresponding multi-level cabinet until the surgical procedureadvances to the rod manipulation stage.

During a surgical procedure in the OR, the three cabinet collection maybe stacked on top of one another in a predetermined order in or a randomorder. For example, the cabinets may be stacked with Stage 1 on top,Stage 2 in the middle and Stage 3 on the bottom, such that asinstruments are removed the overall stack of cabinets becomes lighterfrom the top down over the progression of the surgical procedure.Optionally, the cabinets may be stacked with Stage 3 on top, Stage 2 inthe middle and Stage 1 on the bottom. Optionally, the cabinets may bestacked based on weight such that the heaviest cabinet is on the bottom.Optionally, the cabinets may be stacked such that the cabinet least usedis on the top (or in whichever position is least convenient), while thecabinet most used is at a level most convenient.

Optionally, during the surgical procedure, the cabinet collection may bearranged side by side immediately adjacent one another or spaced apartfrom one another with sufficient space therebetween to allow a tray tobe opened in a direction between the cabinets.

The collection of cabinets provide a substantially savings in “realestate” needed for set up in an O.R setting as compared to a conventionOR set up. When stacked in a single vertical stack, the cabinets onlyoccupy the space of one, two or three instrumentation trays, as theremainder of the trays are stacked in a closed position and locked ontop of one another, but with the ability to access all six levels fromany direction. Embodiments herein significantly reduce “Set up” time asoutlined above, as the medical personnel no longer need to set out everytray with every instrument for the entire procedure and no longer needto reorganize a large number of trays spread over an OR. Embodimentsherein avoid a need for placing instrumentation in a particular order orspacing out of instruments across an OR area.

Embodiments herein substantially reduce a risk of instrumentcontamination that is experienced in convention instrument usage as thecabinets herein retain unused instruments in an enclosed and shelteredstate or environment until used or until at least a select stage of theprocedure. The cabinets afford the ability to “house” instruments untilneeded, therefore reducing time of exposure of instrumentation duringall portions of the stages of the procedures described herein.

Optionally, embodiments herein may standardize cabinets and trays with apredetermined organization of tray order and the instrumentation in thetrays for a more efficient delivery to the O.R. theater.

FIG. 12 illustrates a front perspective view of a cabinet system 1200joined to one another in an O.R. in accordance with an embodimentherein. The cabinet collection 1200 includes a stage-1 multi-levelcabinet 1202, a stage-2 multi-level cabinet 1203 and a stage-3multi-level cabinet 1204. Each of the cabinets 1202-1204 includes frontsides 1214, 1224, 1234, back sides (not shown), and opposite ends 1210,1212, 1220, 1222, 1230, and 1232. Each of the cabinets 1202-1204comprise a housing including a top plate, a bottom shelf and at leastone intermediate shelf there between. The housing separates theintermediate shelf from the top plate and bottom shelf to define firstand second tray storage areas there between. The first and second traystorage areas are configured to receive the first and secondinstrumentation retention trays, respectively. The housing includes traypassages located on at least a side and an end of the housing. The traypassages communicate with the first and second tray storage areas toallow all of the instrumentation retention trays 1240-1247 to beinserted into the corresponding cabinet housing and opened to an openposition relative to the housing in at least two directions. Optionally,the trays 1240-1247 may be removed entirely from the correspondingcabinet housing.

The cabinets 1202-1204 include instrumentation retention trays 1240-1247that are loaded with instrumentation use in connection with first,second and third stages, respectively, of a surgical procedure. Forexample, the stage-1 cabinet 1202 is provided with instrumentationretention trays loaded with instrumentation for use with actions ortasks performed during the first stage of the surgical procedure. Thestage-2 cabinet 1203 is provided with instrument retention trays loadedwith instrumentation for use with actions or tasks performed during thesecond stage of the surgical procedure. The stage-3 cabinet 1204 isprovided with instrument retention trays loaded with instrumentation foruse with actions or tasks performed during the second stage of thesurgical procedure. By way of example, the term “providing” may includeloading the instruments in the instrumentation retention trays andloading the instrumentation retention trays into the stage-1 and stage-2cabinets. Additionally or alternatively, the term “providing” may merelyrefer to taking possession of, and/or using, a pre-loaded tray orcabinet. For example, the use of the cabinets 1202-1204 during asurgical procedure represents one example of how the cabinets 1202-1204are provided with the trays 1240-1247.

In the example of FIG. 12, the stage-1, stage-2 and stage-3 cabinets arestacked on one another. A top 1205 of the stage-1 cabinet 1202 is openedor removed to allow access to the tray 1240, while tray 1242 is slid outof the end 1210 of the cabinet 1202, during the first stage of thesurgical procedure. Once the first stage is complete, the top 1204 maybe closed and the tray 1242 may be closed. During the first stage, thetrays 1243-1247 remain closed in an enclosed and sheltered environmentwithin housings of the cabinets 1203 and 1204. During the second stageof the procedure, one, two or all three of trays 1243-1245 are openedthrough the front/back sides and/or opposite ends 1220, 1222, dependingon the number of passages provided in the cabinet 1203. In the presentexample, the trays 1243-1245 are opened through opposite ends 1220,1222. During the second stage, the trays 1246-1247 of the third stagecabinet 1204 remain closed in an enclosed and sheltered environmentwithin housings of the cabinet 1204. After stage 2, during the thirdstage of the procedure, one or both of trays 1246-1247 are openedthrough the front/back sides and/or opposite ends 1230, 1232, dependingon the number of passages provided in the cabinet 1204. The tray 1246 isslid out from one end and the tray 1247 is slid out through the front1234.

The single cabinets and cabinet systems described herein retain theinstrumentation retention trays closed in an enclosed and shelteredenvironment within the cabinet for a substantial portion of the medicalprocedure, only opening the trays at or near the time when theinstruments therein are to be used. By reducing the amount of time inwhich the instruments are exposed to the environment of the operatingroom or other clinical area, embodiments herein substantially reduce theexposure time to contaminants within the environment and substantiallyreduce the level of contamination experienced by such instruments priorto usage. As explained above, conventional systems expose all of theinstruments for the entire surgical procedure which may last severalhours. In contrast, the cabinets, systems and methods herein allowmedical personnel to keep the instruments in an enclosed and shelteredenvironment until used, or at least until a corresponding stage of amulti-stage surgical procedure.

Optionally, trays may be marked with indicia indicative of a content ofthe tray. For example, when trays are organized for particular aspectsof the procedure, the corresponding aspect may be indicated on the tray.For example, the indicia may indicate color coding, descriptive text,numbers, and the like. The indicia may be included on all or a portionof the sidewalls of the tray. Optionally, when components of the cabinetare formed with aluminum, the component may anodized to affordprotection. Optionally, the anodization process may be used to colorcode areas or complete trays, to include indicia on the tray.Optionally, color coding and other graphical indicia may be provided onthe interior surfaces of the baseplates within the trays. For example,indicia may be used to define outlines or locations for particular typesof instrumentation, thereby facilitating organization and reloading ofan empty tray. In addition, by providing indicia indicative ofindividual tools, embodiments herein afford the ability to provide anindicator to surgical personnel when a particular instrument, implantand the like has been removed from a particular tray.

Optionally, embodiments herein may include a cabinet structure havingshelves that are dimensioned and spaced apart to receive pre-existingtrays therein. For example, a first cabinet may be constructed toreceive existing trays (including existing wire baskets) built by afirst manufacturer and/or a first type of tray, while another cabinetmay be constructed to receive existing trays built by anothermanufacturer. Alternatively, a cabinet may be billed to have differentheights between the shelves where the heights are configured to receiveexisting trays having different side profiles/fights.

In accordance with at least one embodiment, the tray base and shelvesare formed with a generally planar alignment. However, optionally, thetray bases and shelves may be formed in alternative manners to addrigidity, such as in central portions of one or more of the tray basesand shelves. For example, the tray base and/or shelves may be stamped orotherwise shaped to include a non-flat geometry to increase a rigidityof the tray and/or shelf. For example, a center portion of the shelvesand/or trays may be stamped to include ridges, ribs, waves or anothernon-flat geometry. The height of the added structure may vary, such asmolding and or stamping in a quarter inch high ridge along a flatsurface area of the shelf and/or tray base. Optionally, differentcombinations of materials may be utilized for the trays, shelves,corners and/or edges to add strength while reducing weight. As a furtheroption, added structural components may be mechanically attached to thetray bases and/or shelves, such as by adding separate ribs, crossbeams,and the like. As yet a further example, the added structural componentsmay simply represent second, third or fourth layers of the same materialused to form the tray base and/or shelves, with the secondary layerscovering all or only select portions of the main tray base and/orshelves.

It is recognized that the embodiments herein may be implemented invarious types of medical settings and medical procedures, including, butnot limited to spine, ear nose throat, cardio, eye surgery, plasticsurgery and the like. The cabinets described herein afford the benefitsthat include, among other things, a time savings in connection withpreparing an operating room as well as locating instruments desired by aphysician, cost savings, safety, flexibility and reduction incontamination.

CLOSING STATEMENTS

It should be clearly understood that the various arrangements andprocesses broadly described and illustrated with respect to the Figures,and/or one or more individual components or elements of sucharrangements and/or one or more process operations associated of suchprocesses, can be employed independently from or together with one ormore other components, elements and/or process operations described andillustrated herein. Accordingly, while various arrangements andprocesses are broadly contemplated, described and illustrated herein, itshould be understood that they are provided merely in illustrative andnon-restrictive fashion, and furthermore can be regarded as but mereexamples of possible working environments in which one or morearrangements or processes may function or operate.

It is to be understood that the subject matter described herein is notlimited in its application to the details of construction and thearrangement of components set forth in the description herein orillustrated in the drawings hereof. The subject matter described hereinis capable of other embodiments and of being practiced or of beingcarried out in various ways. Also, it is to be understood that thephraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including,” “comprising,” or “having” and variations thereof herein ismeant to encompass the items listed thereafter and equivalents thereofas well as additional items.

It is to be understood that the above description is intended to beillustrative, and not restrictive. For example, the above-describedembodiments (and/or aspects thereof) may be used in combination witheach other. In addition, many modifications may be made to adapt aparticular situation or material to the teachings herein withoutdeparting from its scope. While the dimensions, types of materials andcoatings described herein are intended to define various parameters,they are by no means limiting and are illustrative in nature. Many otherembodiments will be apparent to those of skill in the art upon reviewingthe above description. The scope of the embodiments should, therefore,be determined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled. In the appendedclaims, the terms “including” and “in which” are used as theplain-English equivalents of the respective terms “comprising” and“wherein.” Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects or order ofexecution on their acts.

What is claimed is:
 1. A method of providing a medical instrumentationstorage cabinet, the method comprising: providing first and secondinstrumentation retention trays to receive instrumentation; providing ahousing including a top plate, a bottom shelf and at least oneintermediate shelf there between, one or more of the top plate, thebottom shelf, the intermediate shelf or the first and secondinstrumentation retention trays including a plurality of holes therethrough to allow passage of a sterilization medium during asterilization process, the housing having a front, back and oppositeends; and the intermediate shelf separated from the top plate and bottomshelf to define first and second tray storage areas there between, thefirst and second tray storage areas configured to receive the first andsecond instrumentation retention trays, respectively; the housingincluding tray passages, to the first and second tray storage areas, inthe front and in at least one of the ends of the housing, the traypassages adapted to allow both of the first and second instrumentationretention trays to be inserted into the housing and opened to an openposition through the front and through the at least one of the ends. 2.The method of claim 1, the method further comprising configuring thefirst and second instrumentation retention trays to have a baseplate andwalls at least partially surrounding the baseplate.
 3. The method ofclaim 1, further comprising locating the tray passages in each of theends of the housing to allow inserting and/or opening the firstinstrumentation retention tray through a first end of the housing and anopposite second end of the housing.
 4. The method of claim 1, furthercomprising locating one of the tray passages in a back of the housing toallow inserting and/or opening the first instrumentation retention traythrough the back of the housing.
 5. The method of claim 1, wherein thetray passages are adapted to allow inserting and/or opening the firstinstrumentation retention tray through the front and at least a firstside of the housing; and to allow inserting and/or opening the secondinstrumentation retention tray through the front and at least a secondend of the housing.
 6. The method of claim 1, forming the top plate,bottom and intermediate shelfs and first and second instrumentationretention trays of a sterilization tolerant material.
 7. The method ofclaim 1, further comprising introducing a sterilization medium to thechamber, the sterilization medium propagates through interior passageswithin the cabinet to sterilize surfaces of the cabinet.
 8. The methodof claim 1, further comprising maintaining a space between the first andsecond instrumentation retention trays and bottom and intermediateshelfs to define air passages that allow a sterilization medium to touchupper and lower surface of the first and second instrumentationretention trays and bottom and intermediate shelfs.
 9. The method ofclaim 8, wherein the sterilization medium is at least one of heated air,steam, liquid or vapor chemicals.
 10. The method of claim 1, furthercomprising organizing instrumentation within the first and secondinstrumentation retention trays based on a predetermined procedure suchthat a first set of instrumentation in the first instrumentationretention tray corresponds to a first aspect of the predeterminedprocedure and a second set of instrumentation in the secondinstrumentation retention tray corresponds to a second aspect of thepredetermined procedure.
 11. The method of claim 1, further comprisingmarking the first and second instrumentation retention trays withindicia indicative of a content thereof, wherein the indicia indicate atleast one of color coding, descriptive text, or numbers.
 12. The methodof claim 1, further comprising partially opening a door on one or moreside or end of the cabinet and retaining a portion of the door in railsin the cabinet, the door forming a counterbalance lever to resisttipping by the housing when one or more of the first and secondinstrumentation retention trays is partially removed from thecorresponding first or second tray retention area.
 13. The method ofclaim 1, further comprising providing instrumentation, theinstrumentation including at least one of surgical instruments orimplants.
 14. The method of claim 1, further comprising providingsurgical instruments and implants, at least one of the surgicalinstruments or implants to be stored in at least one of the first andsecond surgical instrument retention trays.
 15. The method of claim 1,further comprising, during a procedure, inserting and/or opening thefirst instrumentation retention tray through the front or a first end ofthe housing and inserting and/or opening the second instrumentationretention tray through the front or a second end of the housing.
 16. Amethod of providing a medical instrumentation storage cabinet for firstand second instrumentation retention trays, the method comprising:providing a housing including a top plate, a bottom shelf and at leastone intermediate shelf there between, one or more of the top plate, thebottom shelf, or the intermediate shelf including a plurality of holesthere through to allow passage of a sterilization medium during asterilization process, the housing including a front, a back andopposite first and second ends, the housing including first and secondtray storage areas between the intermediate shelf, the top plate andbottom shelf; the housing including tray passages to the first andsecond tray storage areas, the tray passages located in the front and inat least one of the first or second ends of the housing, the traypassages adapted to allow the first and second instrumentation retentiontrays to be inserted into the housing and opened to an open positionthrough the front and through at least one of the first or second ends.17. The method of claim 16, wherein the tray passages are located ineach of the first and second ends of the housing.
 18. The method ofclaim 16, wherein one of the tray passages is located in a back of thehousing.
 19. The method of claim 16, wherein the tray passages areadapted to allow insertion and/or opening the first instrument retentiontray through the front and at least a first end of the housing andinsertion and/or opening the second instrumentation retention traythrough the front and at least a second end of the housing.
 20. Themethod of claim 16, wherein the top plate, bottom and intermediateshelfs are formed of a sterilization tolerant material.
 21. The methodof claim 16, further comprising providing the first and secondinstrumentation retention trays.
 22. The method of claim 21, wherein aspace is maintained between the first and second instrumentationretention trays and bottom and intermediate shelfs to define airpassages that allow a sterilization medium to touch upper and lowersurface of the first and second instrumentation retention trays andbottom and intermediate shelfs.
 23. The method of claim 21, furthercomprising providing instrumentation, the instrumentation including atleast one of surgical instruments or implants.
 24. The method of claim23, further comprising organizing the instrumentation within the firstand second instrumentation retention trays based on a predeterminedprocedure such that a first set of instrumentation is in the firstinstrumentation retention tray corresponds to a first aspect of thepredetermined procedure and a second set of instrumentation is in thesecond instrumentation retention tray corresponds to a second aspect ofthe predetermined procedure.
 25. The method of claim 21, furthercomprising providing surgical instruments and implants, at least one ofthe surgical instruments or implants to be stored in at least one of thefirst and second surgical instrument retention trays.
 26. The method ofclaim 21, further comprising loading the cabinet, with the first andsecond instrumentation retention trays, into a chamber and introducing asterilization medium to the chamber, the sterilization medium propagatesthrough interior passages within the cabinet and the first and secondinstrumentation retention trays to sterilize surfaces of the cabinet andthe first and second instrumentation retention trays.
 27. The method ofclaim 21, further comprising, during a procedure, inserting and/oropening the first instrumentation retention tray through the front or afirst end of the housing and inserting and/or opening the secondinstrumentation retention tray through the front or a second end of thehousing.
 28. The method of claim 16, further comprising introducing asterilization medium to the chamber, the sterilization medium propagatesthrough interior passages within the cabinet to sterilize surfaces ofthe cabinet.